A Phase 1 First in Human Study of ARV-393 in Adult Participants With Advanced Non-Hodgkin's Lymphoma
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This clinical trial is studying the safety and potential anti-tumor activity of an investigational drug called ARV-393 in patients diagnosed with advanced Relapsed/Refractory non-Hodgkin's lymphoma (R/R NHL) to determine if ARV-393 may be a possible treatment option. ARV-393 is thought to work by breaking down a protein present in many types of non-Hodgkins lymphomas, which may prevent, slow or stop tumor growth. This is the first time ARV-393 will be used by people. The investigational drug will be given as an oral tablet.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• For Part A and B: Have relapsed/refractory NHL and \>=2 prior systemic therapies, (including rituximab), and be ineligible for known therapies with demonstrated clinical benefit per investigator assessment or, histologically confirmed AITL that has recurred or progressed following institutional standard of care therapy.
• For Part C and D: Have R/R DLBCL, not otherwise specified \[NOS (DLBCL, NOS)\] or large B-cell lymphoma (LBCL) arising from follicular lymphoma and have received two or more lines of systemic therapy.
• Have at least one bi dimensionally measurable lesion \>1.5-centimeter (cm) in largest dimension for nodal or \>1.0 cm for extranodal lesion.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (NOTE: For Part A only - ECOG PS of 2 is allowed for participants with secondary CNS lymphoma).
• Adequate bone marrow function
• Adequate kidney function
• Adequate Liver Function
Locations
United States
Connecticut
Clinical Trial Site
RECRUITING
New Haven
Michigan
Clinical Trial Site
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Detroit
New Jersey
Clinical Trial Site
RECRUITING
New Brunswick
New York
Clinical Trial Site
RECRUITING
New York
Clinical Trial Site
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New York
Ohio
Clinical Trial Site
RECRUITING
Cleveland
Tennessee
Clinical Trial Site
RECRUITING
Nashville
Texas
Clinical Trial Site
RECRUITING
Houston
Other Locations
Canada
Clinical Trial Site
RECRUITING
Montreal
Clinical Trial Site
RECRUITING
Toronto
Denmark
Clinical Trial Site
RECRUITING
Copenhagen
Clinical Trial Site
RECRUITING
Odense C
Spain
Clinical Trial Site
RECRUITING
Barcelona
Clinical Trial Site
RECRUITING
El Palmar
Clinical Trial Site
RECRUITING
Madrid
Clinical Trial Site
RECRUITING
Pamplona
Clinical Trial Site
RECRUITING
Salamanca
Contact Information
Primary
Arvinas Operations, Inc.
clinicaltrialsARV-393@arvinas.com
475-345-0791
Time Frame
Start Date:2024-09-05
Estimated Completion Date:2028-03
Participants
Target number of participants:255
Treatments
Experimental: Part A Monotherapy Dose escalation
Participants with R/R NHL will receive ARV-393 dose escalation beginning at dose level 1
Experimental: Part B Monotherapy: Dose expansion/optimization
Dose expansion and optimization of ARV-393 will be conducted in Part B to determine the recommended phase 2 dose (RP2D) for participants with R/R NHL
Experimental: Part C Combination therapy: Dose escalation
Participants with R/R diffuse large B-cell lymphoma (DLBCL) will receive ARV-393 in combination with glofitamab, beginning at an ARV-393 dose informed by the Part A. Glofitamab will be given per labelled prescribing information. Part C will be conducted in non-USA centers.
Experimental: Part D Combination therapy: Dose expansion/optimization
Part D will be an optimization of ARV-393 in combination with glofitamab to determine a potential RP2D for ARV-393 in the combination regimen. Part D will be conducted in non-USA centers in participants with R/R DLBCL.